Our local offices assist clients with the implementation and management of international clinical programs, including safety reporting. We also assist with US Agent and EU legal representation activities. In the USA, we provide full US Agent services, including IND maintenance under eCTD format.
Our expertise encompasses clinical development for a broad range of products, study populations and indications. Study populations span from pediatric to elderly. A specific expertise has been developed on cell, gene and tissue therapies using a methodology based on risk assessment.
Our project teams interact with external clinical Experts, Key Opinion Leaders and CROs.